Job Description

• Monitor manufacturing compliance to GMP and statutory requirements.
• Monitor adherence to guidelines, procedures, and document controls.
• Deliver expected productivity targets as per business requirements.
• Related administrative tasks.
• Serve as back up to Team Leader on shift.

Planning and Procedures

• Plan and prioritize daily, weekly, and monthly activities
• Determine, request, and use resources/ assets optimally

Inspections and Verifications

• Verify schedule 5 products
• Verify certified clean status of rooms and equipment
• Verify, review, and approve verification of measuring equipment performance, calibrations, and sampling, and dispensing of materials

Line & Production processing

• Perform, review, and approve line sign-ons, closures and clearance authorizations
• Perform, review, and approve batch reconciliations to product specifications and quality
• Ensure production process adherence to standards and specifications

Process and system improvements

• Manage, review, and approve change control programs and deviations/ concessions comply to standards and specifications
• Manage and resolve customer complaints
• Optimize processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus

Compliance & Auditing

• Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Review and approve preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions, and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required

Training and technical expertise

• Train new Pharmacists and PMAs on SOPs in transition period
• Identify refresher or awareness training needs

Administration & Record keeping

• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution

Skills requiredBackground/experience

• Minimum of bachelors degree preferred, ideally in Pharmacy
• 1-3 years related work experience
• Pharmaceutical manufacturing experience
• Registration with Pharmacy Council

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards, and compliance requirements
• Ability to interpret and implement policies, processes, and objectives

Competencies

• Information gathering
• Interrogating information
• Meeting deadlines
• Finalizing output
• Taking action

Aspen Pharmacare